Canadian Doctors for Medicare – the organization I chair – attended the single, closed-door in-person consultation held by Health Canada in April, and we were left with significant questions unanswered about the safety risks associated with the clinics, whether Canada was in need of additional plasma supply, the impact of paid donations on our current voluntary system, as well as why we should change our practice to support a company profiting from Canadian plasma. It’s my opinion that Health Canada should not approve these clinics.

A distinct change in practice

Canadian Plasma Resources stirred up controversy this year when it set up two for-profit clinics where donors would be paid to provide plasma, and applied for license to operate them. Given Canada’s history with tainted blood, this controversy was no surprise. In the 1980s, thousands of Canadians contracted the HIV and hepatitis C viruses – mainly from paid-donor blood that was drawn from riskier populations in the United States. An inquiry by Justice Horace Krever following the tainted blood scandals recommended that Canada should not engage in paying donors for blood or plasma, except in very rare circumstances.

This recommendation has been closely followed in Canada for the last 15 years. However, you would not know this from the Minister’s latest press release announcing the consultation, which overstates Canada’s history of paid donations: “the practice of payment for donations of plasma for the creation of plasma-derived pharmaceuticals has occurred in Canada for 30 years.”

We shouldn’t be fooled that these proposed clinics are more of the same – they would be a sharp break from existing policy. The Minister’s press release referrs to the Cangene facility in Winnipeg, which is the only operation in Canada where paid donation is used, and that’s because it seeks donors with Rh-negative blood, a rare blood type, that produces antibodies for a lifesaving immune globulin medication. This is in keeping with the Krever recommendation that paid donation only be used in rare circumstances – he otherwise recommended that we do not pay donors for blood or plasma in Canada. The Minister is well aware that the Cangene facility is an exception to the rule. I would hope that our government makes policy based on rules, not exceptions.

Canada does import most of its bulk plasma products from the United States, which is derived from paid donors, but Canada does not pay donors directly, and there’s no reason to increase the amount of paid donor blood in the system. The World Health Organization has set a goal of 100% voluntary donations of blood and plasma globally, in recognition that unpaid, voluntary donors are the safest.

Canadian Plasma Resources – who’s getting the plasma?

Canadian Plasma Resources has three fully functional, ready-to-operate plasma donation clinics – despite not yet having approval from Health Canada. CPR makes no secret of its plan to open 10 centres and a fractionation plant, where the plasma can be processed into medications. It’s big business – but with whom are they doing business?

We were told at the consultation by representatives of Canadian Blood Services and Health Canada that CPR does not have a contract with Canadian Blood Services to provide plasma, nor does Canadian Blood Services have a need for more plasma in the near future – our supply is currently adequate.

So the current situation is that Canadian plasma would be provided to any international bidder with whom CPR inks a deal. And Canadians would be a cheap source of plasma, at $20 a pop, to provide CPR with the raw material for drugs like IVIG, which cost thousands of dollars per treatment. What’s more, plasma donors can donate every week, unlike blood donors, who must wait about two months between donations.

Safety risks and the impact on voluntary donations

Although Health Canada is responsible for evaluating the safety and regulatory aspects of Canadian Plasma Resources, it has not examined the impact of these for-profit facilities on our voluntary blood and plasma donation system. We do not know what impact paid donation will have on donors who would otherwise contribute to Canadian Blood Services.

Health Canada also does not consider the location of these facilities, though one is located next to a homeless shelter, and the other next to a drug treatment clinic. Choosing these locations brings up many ethical and public health concerns, including targeting people who may be living in poverty, as well as drawing blood and plasma donations from a population who are at a higher risk of having infectious diseases. While blood screening techniques post-Krever have improved dramatically, we cannot know what the next blood-borne pathogen might be, and we should exercise caution with respect to safety. After all, HIV was once an unknown blood-borne virus too.

As we hurtle toward what seems like a foregone approval of these clinics, we’re left wondering, what public policy goal is met by this fundamental shift in practice? Why would Canada change the safe course it has steered since the Krever inquiry in order to respond to business interests that won’t necessarily address our domestic supply of plasma?

I urge the new Health Minister, Rona Ambrose, and Health Canada not to approve these clinics without a full, frank, open dialogue with Canadians, and a clear public policy rationale for the change. I hope other Canadians will do the same by contacting the Minister.

Monika Dutt is the Medical Officer of Health for Cape Breton, Nova Scotia and formerly the Deputy Medical Health Officer for northern Saskatchewan. She is also the chair of Canadian Doctors for Medicare. Follow her on Twitter @Monika_Dutt

12 comments

how hypocritical!!
¨Canada does import most of its bulk plasma products from the United States, which is derived from paid donors, but Canada does not pay donors directly…¨
So it ethical to pay donors indirectly or if they are not Canadians?
Most of the plasma derived products in the world come from paid donors. Do you consider the Canadian patients in this equation at all?

The rest of the paragraph goes on to say “…and there’s no reason to increase the amount of paid donor blood in the system. The World Health Organization has set a goal of 100% voluntary donations of blood and plasma globally, in recognition that unpaid, voluntary donors are the safest.” I – and CDM – doesn’t advocate for for-profit plasma donation system in any country.

The ideal situation is a voluntary, non-profit system. There are a number of other steps that could be considered before paid for-profit, including paid non-profit.

Canada shouldn’t be considering a for-profit system, particularly when there has been no evidence given that it will benefit Canadians and not cause harm. If the goal is to benefit Canadians, we should be seeking ways to implement a voluntary non-profit system, as other countries have done.

If other countries took the same myopic view about paid plasma donations, Canadians who depend in plasma-based medication would be dying in the streets, because two-thirds of their supply comes from paid donors beyond our borders, mostly Americans.

This is unfortunately an example of some Canadians pushing a myth-supported ideology rather than considering the health outcomes for patients. To support this ideology, the engage in disingenuous tactics:

(1) They cite one recommendation of the Krever inquiry but don’t mention the other with which it is linked: Canada must try to become self-sufficient with its volunteer-based blood and plasma supply. That effort has been ongoing for 15 years and it has failed completely. That is why so much of our plasma-based medicine comes from abroad.

(2) They cite safety issues decades ago for blood and plasma used for transfusion but ignore the safety record of paid plasma donation destined for medication in a process that, to my knowledge, has not suffered any safety breakdown, a process that no expert would suggest raises safety concerns, and they ignore the many studies in the past decade that found no difference in safety between paid and donated plasma. Plasma used for medication is subjected to a battery of tests and processing that is quite unlike that used on plasma destined for transfusion. Those critical differences are not acknowledged by those who oppose paid-plasma, whose focus is not evidence, but in trying to scare people into supporting their ideology.

(3) Every other industrialized nation in the world has paid-plasma for medicine and many have far higher rates of voluntary donation too than does Canada. To suggest paid donation dilutes the pool of volunteer donations is to ignore that record. It is fear-mongering and has no place in reasoned debate.

According to the WHO, 70 countries are completely donation-based, so let’s dispense with the myth that every other country works with paid donation. This is nonsense. Yes, there has been a breakdown in quality. It happens all the time. In 2007 China had to recall IvIG that was tainted with Hep C. That wasn’t supposed to be possible through the fractionation process. There are regular recalls of batches of IvIG by the U.S. FDA. The same U.S. FDA also approved for export the tainted plasma that resulted in the largest public health crisis in this country’s history. More than 40 countries have become self-sufficient, but you don’t do it by closing down the last dedicated free-standing plasma clinic in the country, as CBS did in April 2012. The deputy ministers of health had agreed to increase Canadian content in the mid 2000s, but quickly abandoned the effort after the U.S. supply became more readily available.

I believe your facts are not correct.
Currently CBS has adequate supply of plasma for TRANSFUSION. This is very different from what Canadian Plasma Resources intends to do.
As Canadians we need to enter the current century in regards to plasma protein therapies.
Let’s not rely on an the USA for this. Let’s stop this hypocrisy! Stop closing our eyes when the finished product is being purchased from PAID donors in the USA

Actually Canadian Blood Services was saying that they have enough supply for plasma protein drugs as well as for transfusion. There may be a need down the line, but they said there isn’t a current need, and they don’t have any RFPs out for tender for more plasma protein products. And they certainly haven’t tried to boost domestic voluntary supply very much – they closed the plasma clinic in Thunder Bay last year, claiming they didn’t need the supply – could they not have sent that to fractionation plants to boost protein production?

Stop talking about Canadian patients as though they are in need. This is untrue and complete fear mongering. Having CPR collect and release this plasma onto the open world market to the highest bidder will do NOTHING to ensure Canadians will have access to plasma products should there be another crisis like CJD within the US donor population.

What I don’t understand is why the Canadian Blood Services have been given a free ride in regards to their responsibilities to the Canadian People. If we need more plasma fine, Canadian Blood Services needs to go out there and collect it. Don’t tell me it’s not cost effective to have them so it. If CPR can pay people, collect it, and make a profit Canadian Blood Services could as well. In fact, Canadian Blood Services could use this profit to off-set other costs and reduce their overall budget burden to Canadians. CBS management needs to start doing their job.

There is one other longer term risk that we must keep in mind. If CPR fulfills its long term plan of 10 clinics and a fractionation plant, it is likely that Canadian Blood Services would be under great pressure to buy its products from a Canadian firm, which collects plasma from Canadians. Arguments in favour of this would include both economic development and security of supply. However, in my view, the most important criteria for choosing blood products are, and must remain, therapeutic effectiveness and safety. Right now, Canadian Blood Services is free to choose from any available products on the world market. New technologies can be used as soon as they are available. Fractionation and manufacturing of biological products is complex, and processes are protected by patent and vigorously defended. New and better processes are not immediately available to all firms. Given rapid advancements in things such as monoclonal products, having the flexibility to choose the best products from among the world’s suppliers, without regard to nationalist sentiment, is essential.

This is not a theoretical risk. Canada’s history with Connaught Laboratories is illustrative. Many of Connaught’s fractionated products were widely regarded as inferior. Its manufacturing processes were inefficient, and problems and errors resulted in wasting large volumes of plasma. Connaught was forced to purchase plasma from international brokers to make up the shortfall, and ended up using plasma collected in US prisons. Yet through all this, the Red Cross was pressured to continue to buy from the Canadian firm. The Krever Commission reviewed this history in detail. It should be required reading for anyone considering CPR’s current and future plans.

The ideal situation would be for Canadian Blood Services to collect sufficient plasma from volunteer donors to supply all of Canada’s requirements for plasma derived products, and have that plasma manufactured into products for the Canadian market by whichever manufacturer has the best processes. Such contract fractionation arrangements have been used in the past, and could be used again. There are economy of scale issues to be overcome, but these are not insurmountable.

Several of my friends died as a result of the mistakes made in Canada’s blood system. They were powerful voices reminding people not to repeat those mistakes. Their voices are silent now, but we must all heed their message. Thousands of Canadians lost their lives to hubris about scientific infallibility. We allowed political and economic considerations to override safety, and many Canadian families paid a horrible price. Knowledge of that history is an essential component to the continued vigilance we owe to those who suffered, to ourselves, to our fellow Canadians, and our future generations.

Your main argument is well taken. CBS should buy plasma protein products that provide the best quality and efficacy at a good value and should not have to give preference to any supplier.
However, to say that Canada should not have local industry to process plasma and rely only on foreign private companies because otherwise CBS might be inclined to give preference to the Canadian companies is a joke.
Should we close down all Canadian companies such as Bombardier and … because otherwise some municipality, provincial or the federal government might buy inferior Canadian products using the tax money?

This document is provided under the terms of a CreativeCommons Attribution Non-commercial Share Alike license. The terms of the license are available at: http://creativecommons.org/licenses/by-nc-sa/3.0/. Attributions are to be made to HealthyDebate.ca, a project under the direction of Dr. Andreas Laupacis, at the Keenan Research Centre, Li Ka Shing Knowledge Institute of St. Michael’s Hospital.